Introduction to notified bodies
Selecting a notified body (NB) is essential for medical device manufacturers aiming to sell their products in several key markets, including Europe. However, choosing an NB can be difficult, especially when there is high demand for their services (as is the case at the time of writing this guide).
The Medical Device Regulation (MDR) EU 2017/745 describes the responsibilities and requirements for Notified Bodies (NBs) in Chapter IV��“Notified Bodies (Articles 35��“50).
The designation of NBs under the MDR and IVDR involves a rigorous process to ensure competence, impartiality, and regulatory compliance. Organisations apply to their national authority, undergo thorough assessments, including on-site audits, and, if successful, are formally designated and listed in the NANDO information system with a unique identification number.
Designated NBs are subject to ongoing monitoring, reassessments, and potential changes to their status if compliance issues arise. They must also participate in coordination and peer review activities to maintain consistency across the EU. Manufacturers outside the EU also need a NB to obtain a CE Mark.
Evaluating notified bodies: What matters most
Scope of Designation
The first step is to ensure the NB is designated for the specific medical device being developed and manufactured. Not all NBs cover all categories of medical devices. It is also important to check whether the NB has expertise in the relevant regulations. At present, 45 notified bodies have been designated. 33 NBs are designated under the MDR only, 10 NBs are designated under the MDR and IVDR, and 2 NBs are designated under the IVDR only.
Experience and Competence
Assess the NB’s experience with similar products, including their history of certifications and any publicly available performance metrics. Verify the assessors’ technical expertise and familiarity with the device’s specific technologies and clinical applications. For example, some NBs lack the technical capacity to assess digital health technologies and would be unsuitable for a digital health tool manufacturer.
Capacity and Availability
Ensure the NB has sufficient resources to handle the project within the required timelines. Consider the NB’s initial assessments, audits, and review lead times. Some NBs may have longer wait times due to high demand. This is particularly true when some NBs are not accepting new clients.
Geographic Location
While not always critical, having a notified body nearby facilitates easier communication and quicker on-site audits. Check whether the NB can provide services in all the geographies the company requires. Choose an NB that can operate in the preferred language and understands local regulatory nuances. If the business is multinational, it may be necessary to assess whether the notified body is recognised in all the locations relevant to the company. Verify any additional accreditations or certifications relevant to your device and markets.
Cost
Evaluate the cost structure for the NB services. This includes initial assessment fees, annual audit fees, and additional costs for specific tests or evaluations. Compare the costs with the services and expertise to ensure they offer value for money.
NBs are expected to provide transparency on service pricing and the European Commission maintains a centralised list of links to NB pricing. However, this information may not always be accurate, and requesting individual quotes from each NB can take some time.
Reputation and Reliability
Research the NB’s reputation in the industry using industry forums, peer recommendations, and customer testimonials. Ensure the NB is in good standing with its designating authority and has no significant regulatory or compliance issues. Conferences are a good place to research NBs. Ask other manufacturers about their experiences. Some regulatory consulting companies also track NB performance and make that data available through their newsletters or websites.
Service and Support
Assess the quality of customer service, including responsiveness, clarity of communication, and support during the certification process. Consider the level of support provided after certification, including assistance with post-market surveillance and ongoing compliance. A widespread complaint of NBs is the lack of responsiveness. This has real-world implications, as tardy communications can delay product approvals and certifications.
Audit and Inspection Approach
Understand the NB’s approach to audits and inspections, ensuring they are thorough but not unnecessarily burdensome. Check if the NB can accommodate specific needs, such as scheduling audits and handling non-conformities.
Conflict of Interest
Ensure the NB maintains impartiality and has no conflicts of interest that could compromise the assessment. The medical device world is a small one.
In practice: MedDev Central Insider
In our how-to guides, we like to apply the knowledge to our own situations and challenges so others can see how we use it in real-world scenarios.
MedDev Central’s parent company, Limeburners Bay International, has been looking for a Notified Body for several years. Every medical device company is different, and a single NB is unlikely to fulfil all of an organisation’s needs. Balancing the most critical factors required from an NB can be challenging. It can be helpful to prioritise the most critical factors and take a pragmatic approach to other less essential factors. For Limeburner Bay, the three most critical factors are:
- Ability to assess a wide range of products, including medical devices, IVDs, and digital products.
- The NB must also have a solid international presence across all the company’s locations (Europe, Sub-Saharan Africa, Asia, and the Pacific).
- Since we operate as a social enterprise, price is a significant factor, so we’re also looking for an NB that offers value without compromising on service and support.
We have developed a comparison grid to help collect and compare data on each NB across different factors (available as a digital download). We haven’t decided yet, but we have narrowed the options to two multinational NBs with broad capabilities and presence in our key markets.
Resources
- Designated Notified Bodies: Regulation (EU) 2017/745 on medical devices
- Designated Notified Bodies: Regulation (EU) 2017/746 on in vitro diagnostic medical devices
- European Commission published fees on notified body’s websites for MDR and IVDR related services